Clinical Trial

Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)

Active, Not Recruiting Phase 3
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Summary
This is a Phase III, multi-center, open-label, parallel, 2-arm, randomized study to evaluate the efficacy and safety of radotinib 300 mg Bis In Die(BID) versus imatinib 400 mg Quaque Die(QD). This study will be conducted in Chinese patients with newly diagnosed Ph+ Chronic Myelogenous Leukemia(CML)-Chronic Phase(CP) who are previously untreated for Chronic Myelogenous Leukemia(CML).
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2018-10-25; most recent amendment 2024-10-24.
Status change: Recruiting → Active, Not Recruiting 2022-01-03
Status change: Not Yet Recruiting → Recruiting 2019-02-12
Trial Details
NCT Number NCT03722420
Lead Sponsor Il-Yang Pharm. Co., Ltd.
Conditions Chronic Myeloid Leukemia, Chronic Phase
Enrollment 238 participants
Start Date 2018-12-28
Primary Completion 2023-03-03 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-28